Kornimate/medical-research-clean huggingface dataset:
comparison of two methods of bronchial methacholine provocation

Conditions: Bronchial Hyperreactivity; Bronchial Asthma

Summary: this study is meant to compare two routine diagnostic approaches in patients with bronchial asthma. patients are challenged with methacholine in order to measure their bronchial response. we compare the evaluation of the effects of incremental concentrations versus incremental dosages.

bronchial methacholine challenge is well established in asthma diagnostic and research purposes. ats guidelines provide a short five-breath dosimeter protocol using a five-step dilution schedule. the viasys aps system enables a feasible and less time consuming provocation with incremental dosages. in 48 young adults with bronchial hyperreactivity (bhr) the ats-protocol with a five-step protocol using a single dilution of 16 mg/ml methacholine should be compared.

Eligibility criteria:
inclusion criteria: * informed consent * age 12-45 years * known bronchial hyperreactivity exclusion criteria: * age \ 45 years * clinical asthma requiring regular inhalation * vital capacity \< 80% * fev1 \< 75% * chronic disease conditions or infections * pregnancy * inhalative or systemic steroid use * substance abuse * incapability of understanding the study's purpose and performance

Keywords: pc20 fev1 pd20fev1 bronchial hyperreactivity bronchial asthma
prevalence and recognition of cognitive impairment in hospitalized patients: a flash mob study

Conditions: Cognitive Impairment; Dementia; Alzheimer Disease; Delirium

Summary: the aim of this multicenter, cross-sectional, observational flash mob study is to investigate the prevalence of cognitive impairment in hospitalized elderly aged 65 years or older, and the recognition of cognitive impairment by healthcare professionals.


Eligibility criteria:
inclusion criteria: * dutch-speaking * hospitalized * age ≥ 65 years old exclusion criteria: * unable to perform the mini-cog (e.g. due to visual impairment, severe hearing loss, being too ill, or otherwise unable to speak or write) * patients who require medical isolation * not willing to participate.

Keywords: elderly hospitalization
pain inhibition and facilitation in recurrent low back pain

Conditions: Recurrent Low Back Pain; Healthy

Summary: this study evaluates psychophysical measures of pain inhibition and facilitation, along with cortical responses to different sensory stimuli, in patients with recurrent low back pain and matched healthy individuals.

pain inhibitory and facilitatory mechanisms have been suggested to play a role in the development of persistent low back pain; however, there is still debate on when changes in these mechanisms occur. similarly, evoked cortical responses can reflect neuroplastic changes in pain processing regions, which are also thought to play a role in the transition to persistent pain, but there is also debate on when these neuroplastic changes develop relative to low back pain. therefore, this study will use patients with an intermediary clinical pain state, recurrent low back pain, and matched healthy control participants, to investigate within and between subject differences in pain inhibitory, facilitatory and neuroplastic mechanisms.

Eligibility criteria:
inclusion: * healthy men and women * aged 18-60 years * no previous back pain or \>1 previous episode of low back pain in past 12 months * no current back pain or pain in the region posteriorly between the inferior border of the 12th rib and the lower gluteal fold (low back pain) at time of recruitment lasting \>24 hours * able to speak, read and understand english exclusion: * pregnancy * first episode of low back pain * low back pain associated with menstruation * chronic low back pain (continuous pain episode for \>3 months) * currently seeking active treatment for low back pain * red flags symptoms * drug addiction defined as the use of cannabis, opioids or other drugs * current or previous neurologic, musculoskeletal, mental, or other illnesses which may affect the trial * current or previous chronic or recurrent pain condition other than low back pain * current regular use of analgesic or other medication which may affect the trial * lack of ability to cooperate * recent history of acute pain particularly in the lower limbs (unless related to lbp) * abnormally disrupted sleep in 24 hours preceding experiment
a study of icp-022 in the treatment of recurrent or refractory waldenstrom macroglobulinemia

Conditions: Waldenstrom's Macroglobulinemia Recurrent; Waldenstrom's Macroglobulinemia Refractory

Summary: the phase ii clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of icp-022. safety, tolerability evaluation, and anti-tumor effects of icp-022 in chinese patients with r/r wm will be evaluated in approximately 44 subjects. pharmacokinetics of icp-022 will be evaluated in approximately 20 subjects.


Eligibility criteria:
key inclusion criteria: 1. clinical and histologically confirmed giant globulinemia fahrenheit (wm ii international working group standards, iwwm-2, 2003) (owen et al., 2003) 2. at least one treatment indication is met (7th wm international working group standards, iwwm-7) (dimopoulos et al., 2014) 3. with the lowest serum igm value \>2 times uln as the efficacy evaluation index 4. ecog physical strength score 0-2 5. voluntary written informed consent prior to trial screening. key exclusion criteria: 1. present or prior history of other malignant neoplasms, unless radical treatment has been performed and there is no evidence of recurrence or metastasis in the last 5 years 2. amyloidosis and central nervous system (cns) involvement caused by wm 3. demonstrate disease transformation 4. patients who had received autologous stem cell transplantation within the previous 6 months 5. a history of organ transplantation or allogeneic bone marrow transplantation note: other protocol defined inclusion/exclusion criteria may apply.
comparison between the results of open and microsurgical decompression in degenerative spinal canal stenosis in lumbar spine

Conditions: Degenerative Lumbar Canal Stenosis

Summary: to compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine

lumbar spinal stenosis is defined as a circumscribed, osteoligamentous narrowing of the spinal canal. the clinical burden includes backaches and symptoms in the legs that deteriorate upon standing and walking (neurogenic claudication). lumbar spinal stenosis is the most common cause of lumbar spine diseases in patients \> 65 years old requiring surgical treatment; it is estimated that ∼0.1% of the population will need some procedure to treat degenerative lumbar spine conditions. surgical treatment for lumbar spinal stenosis is indicated in cases of conservative treatment failure. it is also indicated in cases with very acute symptoms and radicular involvement associated with dermatome sensorial and motor changes and progressive worsening of severe neurogenic claudication. vertebral canal decompression can be performed with several techniques. the gold standard is the open technique with laminectomy or laminotomy, in which laminae are resected or opened; next, the ligamentum flavum, usually thickened, is resected, exposing the nervous structures under compression. laminotomy can be unilateral, bilateral or divide the spinous process. damaging the paraspinal muscles and liberal removal of posterior bone may cause iatrogenic spinal instability. the microsurgical spinal canal decompression decreases paravertebral musculature injury, reducing postoperative complications related to hematomas, seromas and infections and trunk extensor musculature atrophy. the dural sac is decompressed after its exposure and removed to allow the resection of the lateral recess and foramen opening to decompress an adjacent and/or emerging nerve root. it is believed that mis may limit surgery-related morbidity and mortality by reducing the degree of surgical trauma while maintaining similar surgical outcomes.

Eligibility criteria:
inclusion criteria: patients present with degenerative lumber spinal canal stenosis in one or two level exclusion criteria: 1. degenrative listhesis. 2. degenerative scoliosis. 3. other secondary causes of lumber canal stenosis as tumor , abscesses and infection. 4. patients with previous lumbar operation
impact of active video game on cardiorespiratory, macro and microcirculation function of adolescents with overweight

Conditions: Overweight and Obesity; Cardiovascular Risk Factor; Physical Activity

Summary: this study evaluates the effects of physical exercise through active videogame in the microcirculation, macrocirculation, cardiorespiratory function and physical fitness in overweight adolescents. for that, they will be randomized into two groups, one being a control group and the other intervention group. the randomization will be made by school. the intervention group will perform the physical exercise through the active video game, three times a week, for 50 minutes, during 8 weeks. reassessments will be performed before and after the intervention to evaluate the outcome variables.


Eligibility criteria:
inclusion criteria: * overweight or obese adolescent * students enrolled in public schools exclusion criteria: * motor, cognitive or pulmonary limitation * genetic syndrome * pregnancy * use of medication that changes the lipid or glucose profile * not being treated for overweight

Keywords: adolescents obesity lung function microcirculation intima media thickness
young adult congenital heart disease physical activity lifestyle study (yachd-pals)

Conditions: Cardiovascular Disease Other; Physical Activity

Summary: this study will adapt a physical activity lifestyle intervention to emerging adult congenital heart disease (chd) survivors with the primary goal of increasing physical activity levels. the study will be split into 2 phases. in phase 1, participants will be asked to complete questionnaires, wear an accelerometer around the waist for 7 days, and undergo an exercise stress test. the accelerometer and exercise stress test will be used to determine whether participants are eligible to be randomized for the intervention study. in phase 2, participants will be randomized to one of two conditions: 1) receiving a physical activity tracker (a fitbit) or 2) receiving a fitbit and engaging in videoconferencing sessions with a physical activity coach. during phase 2, participants will also be asked to complete 3 assessments (weeks 9 and 22, and a 6-month follow-up). the week 9 assessment will consist of completing questionnaires and wearing an accelerometer for 7 days. week 22 will be similar to week 9 with the addition of a final exercise stress test. the 6-month follow-up will mirror the week 9 assessment. participants who are randomized to the videoconferencing condition will be asked to meet with a physical activity coach 8 times over the course of 20 weeks. coaches will help participants to (1) change attitudes toward physical activity, (2) increase perception of others' approval of physical activity (e.g., family members, peers), and (3) increase participants' perceived control by troubleshooting barriers and increasing efficacy for physical activity. coaches will use the fitbit to facilitate self-monitoring and goal setting. participants in the intervention arm will be asked to participate in a focus group at the conclusion of the study to share their experiences.


Eligibility criteria:
inclusion criteria: 1. between the ages of 18-25 (if 18, must no longer be in high school and no longer living at home) 2. are diagnosed with moderate or complex structural congenital heart disease 3. live within 120 miles of nationwide children's hospital exclusion criteria: 1. do no speak or write proficiently in english 2. have cognitive impairments that would interfere with the completion of study procedures 3. are diagnosed with a genetic syndrome (e.g., downs, marfans) 4. have been engaged in a formal exercise program within the past 6 months 5. underwent open-heart surgery or have had a transcatheter valve replacement in the last 3 months 6. are otherwise prohibited by their cardiologist to engage in at least moderate levels of physical activity 7. are unable to complete a treadmill-based exercise stress test 8. are currently pregnant 9. have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia) 10. \>150 min/weekday of moderate-to-vigorous physical activity per the accelerometer 11. do not have access or a device for videoconferencing with the coach

Keywords: congenital heart disease physical activity
correlation between triglyceride glucose index and residual syntax score in stemi patients undergoing ppci

Conditions: STEMI - ST Elevation Myocardial Infarction

Summary: the goal of this study to check correlation between triglyceride glucose (tyg) index and residual syntax score (rss) in stemi patients undergoing ppci. 2. impact of both tyg index and rss in stemi patients undergoing ppci on lv ef recovery after 3 months using lv speckle tracking. 3. impact of rss and tyg index in stemi patients undergoing ppci on short term mace at 3 months duration.

st-elevation myocardial infarction (stemi) is known as a life-threatening complication of coronary artery disease (cad) and it is one of the leading causes of death all over the world. primary percutaneous coronary intervention (ppci) of the culprit vessel in patients with stemi is standard clinical practice . at the time of ppci, 40-65% of the patients exhibit one or more concomitant coronary lesions (i.e., multivessel disease (mvd)). the presence of narrowed coronaries other than those related to index ischemia in patients with stemi is suggested as a feature associated with adverse clinical outcomes . the recently developed residual syntax score (rss) (developed 2012 and validated in 2013) is an objective, quantitative measure of the degree and complexity of residual stenosis after percutaneous coronary intervention (pci) .it was developed to quantitatively assess the degree and complexity of residual stenoses, based on recalculating the syntax score from coronary angiography after pci . higher rss has been associated with worse outcome in patients undergoing angiography-mediated pci . insulin resistance (ir) is an important risk factor for the development of cad . it is defined as a state in which a greater than normal amount of insulin is required to elicit a quantitatively normal response . previous studies have shown an independent association between ir and cvd. ir is tightly associated with increased cardiovascular morbidity and mortality by adversely modifying well-established cardiovascular risk factors such as dyslipidemia and hypertension and by causing endothelial dysfunction .

Eligibility criteria:
inclusion criteria: * all patient who are between 18 and 80 years old who present to our hospital (assiut university heart hospital) with stemi and eligible for primary pci as treatment of choice according to guidelines, will be included in our study. exclusion criteria: * patient who refuse to undergo revasculariztion using primary pci. * patient who will die before withdraw of laboratory blood sample. * patient with previous pci and/or cabg. * patient with underlying co-morbidity with life expectancy less than 1 year (end stage liver disease, end stage renal disease on regular dialysis, active malignancy). * patient with failed canalization of infarct related artery. * patient referred to cabg after angiography. * patient who is unconscious after cardiac arrest .
caring for caregivers and people living with dementia under home-based primary care

Conditions: Dementia; Quality of Life; Caregiver Stress

Summary: the goal of this clinical trial is to develop a dementia care intervention for persons receiving home-based primary care (hbpc) and living with dementia (plwd) and their caregivers, and test the feasibility of implementing the intervention in hbpc practices to ultimately improve outcomes of plwd and their caregivers. the main aims are to: * develop and refine hbpc dementia care quality at home * establish feasibility (primary outcome), acceptability, and fidelity of hbpc dementia care quality at home through an open-pilot trial involving two hbpc practices. trained clinicians and staff at two hbpc practices will implement the intervention relevant stakeholders (caregivers of plwd, and hbpc clinicians and staff) will participate in qualitative focus groups to provide feedback on the intervention.

the overarching goal of this project is to develop a dementia care intervention for plwd and their caregivers, dementia care quality at home, and test the feasibility of implementing the intervention in two hbpc practices to ultimately improve outcomes of plwd and their caregivers. the investigators will evaluate the feasibility, acceptability, and fidelity in implementing hbpc dementia care quality at home in two practices for persons living with dementia and their caregivers through an open pilot. hypothesis: hbpc dementia care quality at home will meet benchmarks of feasibility, acceptability, and fidelity by the hbpc practices implementing it and by caregivers of plwd who experience the intervention. the investigators will assess feasibility of caregivers of plwd to engage with the intervention, the acceptability of the intervention to caregivers, and the impact of the intervention on caregiver well-being by surveying caregivers at the conclusion of the pilot. in addition, the investigators will assess feasibility, acceptability, and fidelity of the intervention in the practices.

Eligibility criteria:
inclusion criteria: caregiver participants will: * be adults (18 years or older) * have english fluency and literacy * live in the united states * live with and care for an individual with alzheimer's disease and alzheimer's disease related dementias (adrd) * anticipate providing care for the next 6 months * provide an average 4 hours of supervision or direct assistance per day for the care recipient and * have been identified by the practice as experiencing caregiver stress. staff participants will: * be 18 years or older * have english fluency and literacy and live in the united states and * be part of a hbpc primary care program or closely connected to the practice. exclusion criteria: * participants under the age 18. * participants who have no english fluency and literacy and do not live in the united states. * for caregiver participants, not caring for and living with a patient that is part of a hbpc primary care program or closely connected to the practice.
optic nerve sheath evaluation in giant cell artheritis by ultrasound

Conditions: Giant Cell Arteritis (GCA)

Summary: the purpose of this study is to evaluate whether the measure of the optic nerve sheath is a reliable diagnostic marker for giant cell arteritis

giant cell arteritis (gca) is a vasculitis affecting large and medium-sized vessels. it predominantly occurs in women, with a sex ratio of 3:1, and mainly affects individuals around 70 years of age. gca is a rare condition, with an incidence of approximately 10 cases per 100,000 people in france. current recommendations suggest using imaging techniques and/or temporal artery biopsy (tab) based on the clinical resources available. the key challenge in suspected cases of gca is to establish a rapid diagnosis. it is important to note that false-negative imaging results may occur if corticosteroid treatment is initiated prior to imaging: after 3 days for pet-ct, 5 to 7 days for doppler ultrasound, and up to 14 days for tab. diagnosing gca is not always easy and depends on depends on the prompt performance of complementary examinations. studies have shown that the optic nerve sheath is thickened on ultrasound in patients with gca. in this context, the investigator aims to evaluate the measurement of the optic nerve sheath via ultrasound for diagnosing gca. ultrasound offers a faster, non-invasive, widely available, and cost-effective diagnostic tool.

Eligibility criteria:
inclusion criteria: * patient with suspected gca * patient over 50 years exclusion criteria: * patient with history of gca * patient with a history of polymyalgia rheumatic (pmr) without initial pet scan * patient with a history of retinal disease, demyelinating disease, or intracranial hypertension * use of corticosteroids \> 0.5mg/kg in the last 2 weeks

Keywords: giant cell arteritis optic nerve sheath ultrasound
antiretroviral therapy adherence and secondary prevention of human immunodeficiency virus

Conditions: HIV

Summary: in this study, investigators propose to randomize 165 human immunodeficiency virus positive patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care + cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence reminders and contingency management. in this latter condition, patients will earn reinforcement for sending in time- and date-stamped self videos of antiretroviral therapy medication ingestion. primary outcomes will include viral loads and self-report measures of adherence, and effects will be evaluated both during the treatment period and throughout a one-year follow-up. investigators hypothesize that the cell phone reminder condition will improve adherence relative to standard care, and the cell phone reminder plus contingency management condition will have the best outcomes. results from this study may have widespread implications for the use of cell phones as a novel technology to improve initial adherence to antiretroviral therapy, thereby reducing the spread of drug resistant human immunodeficiency virus strains to the community.


Eligibility criteria:
inclusion criteria: * age \> 18 years * initiating or on an antiretroviral therapy regimen and have a viral load \>200 copies/ml in the past 6 months * one or more risk factors for poor adherence * english speaking * willing to use a cell phone to receive reminders and record medication ingestion for up to 16 weeks * able to read at 5th grade level and pass a brief quiz related to understanding the informed consent form exclusion criteria: * living in an environment or has a visiting nurse that dispenses antiretroviral therapy medication * participating in another antiretroviral therapy adherence study * uncontrolled psychiatric disorders * significant cognitive impairment

Keywords: hiv antiretroviral therapy adherence
targeted hypoglossal neurostimulation study #3

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the imthera medical aura6000 system as a potential therapeutic option for individuals with moderate to severe osa that have failed or do not tolerate pap.

the objectives of this study are to evaluate the safety and effectiveness of the aura6000 system for the treatment of moderate to severe obstructive sleep apnea (osa) in individuals who have failed or do not tolerate positive airway pressure (pap) therapy or have failed or are intolerant of or refuse indicated alternative osa treatments (such as oral appliances, positional devices and conventional sleep surgeries). pap failure is defined as an inability to eliminate osa (ahi \> 20 despite pap usage) and pap intolerance is defined as: 1) inability to use pap (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or 2) unwillingness to use pap (for example, a patient returns the pap system after attempting to use it). the results of this study are anticipated to provide reasonable assurance of the safety and effectiveness of the aura6000 system when used as intended and to support the application for fda premarket approval of the system.

Eligibility criteria:
inclusion criteria: * age \>18 years * individual has failed or does not tolerate pap therapy * has failed or refuses alternative osa treatments (e.g.surgery, oral appliances, and behavioral treatments) * ahi ≥ 20 (moderate to severe osa) exclusion critera: * implanted with another active implantable device * body mass index (bmi) ≥ 35 kg/m²

Keywords: obstructive sleep apnea